(142 days)
For in vitro diagnostic use.
DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.
DakoCytomation Beta-2-Microglobulin Kit is an in vitro diagnostic assay device for the quantitative determination of human beta-2-microglobulin. Beta-2-microglobulin (B2M), a low molecular weight polypeptide of 11,800 daltons, is the light chain component of the major histocompatibility antigen (HLA). B2M is present on the membrane surface of all cells that express major histocompatibility antigens and it is normally present in the circulation as a result of cell membrane turnover.
The Beta-2-Microglobulin device is similar in design, materials and intended use to other 510(k) cleared devices, which are in commercial distribution.
The provided document is a 510(k) summary for the DakoCytomation Beta-2-Microglobulin Kit. It describes the device's intended use and demonstrates its substantial equivalence to a predicate device. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions "significant interference is defined as recovery within ± 10% at β2M > 6 mg/L or within ± 0.6 mg/L at β2M ≤ 6 mg/L" for interfering substances. This can be considered an acceptance criterion for interference.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Interfering Substances: No significant interference defined as recovery within ± 10% at β2M > 6 mg/L or within ± 0.6 mg/L at β2M ≤ 6 mg/L. | Hemoglobin concentrations up to 1000 mg/dL, bilirubin (conjugated) up to 60 mg/dL and triglyceride up to 1500 mg/dL do not significantly interfere with the assay. |
| Lower Detection Limit (Serum): | 0.3 mg/L |
| Assay Range (Serum): | 0.3 to 20 mg/L |
Note: The document states that the new device meets these criteria but does not provide raw data or specific study results beyond stating that "do not significantly interfere." It primarily focuses on comparing features with the predicate device.
2. Sample size used for the test set and the data provenance:
- Not explicitly stated. The document describes the device and its intended use, and compares it to a predicate. It mentions interference studies but does not provide sample sizes or the origin (country) of the data, nor whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not stated. This device is an in vitro diagnostic kit, not an AI-powered diagnostic tool requiring expert interpretation of images or other subjective data for "ground truth" establishment in a traditional sense. The "ground truth" for this type of device would typically be established through analytical validation studies against reference methods or clinical samples with known analyte concentrations, not through expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable / Not stated. See explanation for #3. Adjudication methods are relevant for subjective interpretations, which is not the primary output for this type of quantitative assay.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is an in vitro diagnostic kit, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The DakoCytomation Beta-2-Microglobulin Kit is a standalone diagnostic assay (an algorithm in this context refers to the chemical reactions and measurement principles), and its performance is evaluated independently. The device's output (quantitative beta-2-microglobulin levels) is directly used for diagnosis, not as an aid for human interpretation in the way AI imaging tools are used.
7. The type of ground truth used:
- For an in vitro diagnostic assay like this, the "ground truth" is typically established through:
- Reference methods: Comparing results to a gold standard method for measuring beta-2-microglobulin.
- Known concentration samples: Testing samples with precisely determined concentrations of beta-2-microglobulin.
- Clinical samples with established clinical diagnoses: While the assay aids in diagnosis, its accuracy is validated by its ability to correctly quantify the analyte in samples from patients with and without the conditions of interest (rheumatoid arthritis, kidney disease) where the true B2M levels are well-characterized.
- The document implies that the device accurately measures beta-2-microglobulin, which is the underlying "ground truth" it's designed to detect.
8. The sample size for the training set:
- Not applicable / Not stated. This device is a chemical assay kit, not a machine learning or AI model that requires a "training set" in the computational sense. Its performance is based on its chemical and immunological principles, not on being trained on a dataset.
9. How the ground truth for the training set was established:
- Not applicable / Not stated. (See explanation for #8).
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.